NeuroPace Initiated With Buy on Breakthrough RNS Label Expansion Opportunity and Strong NAUTILUS Efficacy Data

Analyst Yi Chen from H.C. Wainwright reiterated a Buy rating on NeuroPace and keeping the price target at $18.00.

Yi Chen has given his Buy rating due to a combination of factors tied to NeuroPace’s clinical progress and regulatory outlook. He highlights that the company has filed a Premarket Approval Supplement with the FDA to expand the RNS system’s label to include patients with antiseizure medication–resistant idiopathic generalized epilepsy with generalized tonic-clonic seizures, a group that currently lacks approved neuromodulation options. Supported by the Breakthrough Device designation and typical 180-day review timelines for supplements, he believes label expansion could realistically occur in the first half of 2026, opening a new market opportunity. This potential, together with the company’s reiterated $18 price target, underpins his positive stance on the stock.
Yi Chen also points to compelling data from the NAUTILUS study as a key driver of his recommendation. Eighteen-month interim results showed a 77% median reduction in generalized tonic-clonic seizures from baseline, with strong physician and patient assessments of improvement and a safety profile consistent with prior RNS experience. While the trial did not achieve statistical significance on its primary endpoint related to time to a second seizure at 12 months, it delivered robust and clinically meaningful benefits across several predefined secondary measures, including a 79% median seizure reduction at one year that surpassed outcomes from the earlier pivotal trial in focal epilepsy. In his view, these data suggest the RNS system could offer a transformative treatment option for a difficult-to-treat patient population, supporting both clinical adoption and long-term revenue growth, and justifying the Buy rating.

In another report released yesterday, Lake Street also reiterated a Buy rating on the stock with a $20.00 price target.